METFORMIN XR is a prescription medicine that is FDA approved to treat Type 2 diabetes mellitus when hyperglycemia cannot be managed with diet and exercise alone.

When prescribed off-label METFORMIN XR may help some adults with overweight or obesity lose weight and keep the weight off.

What is the most important information I should know about METFORMIN XR tablets?

Serious side effects can happen in people taking METFORMIN XR tablets, including:

Stop taking METFORMIN XR tablets and call your healthcare provider right away if you get any of the following symptoms of lactic acidosis:

• feel very weak and tired
• have unusual (not normal) muscle pain
• have trouble breathing
• have unusual sleepiness or sleep longer than usual
• have unexplained stomach or intestinal problems with nausea and vomiting, or diarrhea
• feel cold, especially in your arms and legs
• feel dizzy or lightheaded
• have a slow or irregular heartbeat

You have a higher chance of getting lactic acidosis if you:

• have kidney problems. People whose kidneys are not working properly should not take METFORMIN XR tablets.
• have liver problems.
• have congestive heart failure that requires treatment with medicines.
• drink a lot of alcohol (very often or short-term "binge" drinking).
• get dehydrated (lose a large amount of body fluids). This can happen if you are sick with a fever, vomiting, or diarrhea. Dehydration can also happen when you sweat a lot with activity or exercise and do not drink enough fluids.
• have certain x-ray tests with injectable dyes or contrast agents.
• have surgery.
• have a heart attack, severe infection, or stroke.
• are 80 years of age or older and have not had your kidney function tested.

Do not take METFORMIN XR tablets if you:

• have kidney problems
• have an abnormal creatinine level (not to exceed 500mg daily)
• are allergic to the metformin in METFORMIN XR tablets or any of the ingredients in METFORMIN XR tablets. See the medication guide for the full list of ingredients.
• are going to get an injection of dye or contrast agents for an x-ray procedure or if you are going to have surgery and not able to eat or drink much. In these situations, METFORMIN XR tablets will need to be stopped for a short time. Talk to your healthcare provider about when you should stop METFORMIN XR tablets and when you should start METFORMIN XR tablets again.

What should I tell my healthcare provider before taking METFORMIN XR tablets?

Before taking METFORMIN XR tablets, tell your healthcare provider if you:

• have type 1 diabetes. METFORMIN XR tablets should not be used to treat people with type 1 diabetes.
• have a history or risk for diabetic ketoacidosis (high levels of certain acids, known as ketones, in the blood or urine). METFORMIN XR tablets should not be used for the treatment of diabetic ketoacidosis.
• have kidney problems.
• have an abnormal creatinine level
• have liver problems.
• have heart problems, including congestive heart failure.
• are older than 80 years. If you are over 80 years old you should not take METFORMIN XR tablets unless your kidneys have been checked and they are normal.
• drink alcohol very often, or drink a lot of alcohol in short-term "binge" drinking. are taking insulin.
• have any other medical conditions.
• are pregnant or plan to become pregnant. It is not known if metformin will harm your unborn baby. If you are pregnant, talk with your healthcare provider about the best way to control your blood sugar while you are pregnant.
• are breast-feeding or plan to breast-feed. It is not known if metformin passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby while you take METFORMIN XR tablets.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

• METFORMIN XR tablets may affect the way other medicines work, and other medicines may affect how METFORMIN XR tablets work.

Common side effects of METFORMIN XR tablets include diarrhea, nausea, and upset stomach. These side effects generally go away after you take the medicine for a while. Taking your medicine with meals can help reduce these side effects. Tell your healthcare provider if the side effects bother you a lot, last for more than a few weeks, come back after they've gone away, or start later in therapy. You may need a lower dose or need to stop taking the medicine for a short period or for good.

About 3 out of every 100 people who take METFORMIN XR tablets have an unpleasant metallic taste when they start taking the medicine. It lasts for a short time.

METFORMIN XR tablets rarely cause hypoglycemia (low blood sugar) by themselves. However, hypoglycemia can happen if you do not eat enough, if you drink alcohol, or if you take other medicines to lower blood sugar.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient. The product information provided is intended only for residents of the United States. The products discussed herein may have different product labeling in different countries.